Lubricant Eye Drops
- Manufacturer
- MFB Global LLC | DrSignal BioTechnology Co., Ltd.
- Effective date
- 2021-11-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:44:49
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Sodium Hyaluronate 1%
OTC - PURPOSE SECTION
Lubricant
DOSAGE & ADMINISTRATION SECTION
For the temporary relief of burning and irritation due to dryness of the eye.
For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
For use as a protectant against further irritation or to relieve dryness of the eye.
For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Relieves redness of the eye due to minor eye irritations.
WARNINGS SECTION
For external use only
OTC - DO NOT USE SECTION
if solution changes color or becomes cloudy.
USER SAFETY WARNINGS SECTION
if you have narrow angle glaucoma.
OTC - WHEN USING SECTION
To avoid contamination, do not touch tip of container to any surface. ■ Replace cap after using. ■ Overuse of this product may produce increased redness of the eye. ■ Pupils may become enlarged temporarily.
OTC - ASK DOCTOR SECTION
if ■ you experience eye pain, changes in vision, continued redness or irritation of the eye. ■ the symptom worsens or persists for more than 72 hours.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help of contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
Instill 1 or 2 drops in the affected eye(s) as needed up to four times daily.
OTHER SAFETY INFORMATION
Keep refrigerated. Store at 4-10℃(39-50℉). ■ Tamper Evident. Do not use if ring around the bottom of bottle cap is broken or missingminor eye irritations.
INACTIVE INGREDIENT SECTION
Polyquaternium 1
Purified Water.
PATIENT COUNSELING INFORMATION
1-646-339-5789
SPL UNCLASSIFIED SECTION
Manufacturer: DrSignal BioTechnology Co., Ltd. (No. 2-1, Ln. 181, Sec. 2, Jiuzong Rd., Neihu Dist., Taipei City 114, Taiwan)
Distributor: MFB Global LLC
(136-17 39th Ave Suite 301, Flushing, NY 11354, USA) Tel: 1-646-339-5789
Made in Taiwan
DESCRIPTION SECTION
product information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82357-1101-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-d826-0266-e053-dadaa90a7c1a | cfb13935-6e77-73f0-e053-2a95a90ab3c5 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82357-1101-1 | Lubricant Eye Drops | 3 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 3 | 2 | |
| 82357-1101-2 | Lubricant Eye Drops | 1 in 1 BOX | SOLUTION/ DROPS | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82357-1101 | LUBRICANT EYE DROPS (SODIUM HYALURONATE) SOLUTION/ DROPS [MFB GLOBAL LLC] | 2 | Legacy NDC, 2 package rows | 20211109_cfb13935-6e77-73f0-e053-2a95a90ab3c5.zip |
Products#
Every source-derived product name is available through these pages.
- Lubricant Eye Drops
- Sodium hyaluronate
- HYALURONATE SODIUM
- HYALURONIC ACID
- WATER
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- POLIDRONIUM CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82357-1101 | 82357-1101-1, 82357-1101-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYALURONATE SODIUM | YSE9PPT4TH | ACTIB |
| WATER | 059QF0KO0R | IACT |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIM |
| POLIDRONIUM CHLORIDE | 6716Z5YR3G | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d03d3be9-d867-2aad-e053-2995a90aec8c | cfb13935-6e77-73f0-e053-2a95a90ab3c5 | 2021-11-07 | Warnings | d03d3be9-d867-2aad-e053-2995a90aec8c cfb13935-6e77-73f0-e053-2a95a90ab3c5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
